A randomised comparative clinical study to evaluate the dermal safety and efficacy of panchavalkala kashaya extract shower gel and himalaya gentle baby wash on the skin parameters of toddlers.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- PANCHAVALKALA KASHAYA EXTRACT SHOWER GEL MAY BE MORE EFFECTIVE ON DERMAL SAFETY WHEN COMPARED TO HIMALAYA GENTLE BABY WASH.
研究概览
简要总结
According to Evidence based guidelines for infant bathing Shower gels are considered to be safe rather than bathing with water alone or by using soaps in newborn and infants A mild liquid cleanser with water is more effective than water alone at removing damaging substances like faeces urine and food residues from skin surface So considering all these present study is planned where the kashaya extract of Panchavalkaladrugs will be made into shower gel form and it is designed to be mild and nourishing keeping the toddlers skin clean soft and healthy when used for bathing As Himalya gentle baby wash is ph balanced and prooven to be skin friendly hence a comparative study among these 2 is choosen
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Year(s) 至 3.00 Year(s)（—）
- 性别
- All
入选标准
- •1 MEDICALLY STABLE TODDLERS WITH NO DERMATALOGICAL CONDITIONS AND WITH NO REQUIREMENT OF ANY OTHER DRUGS.
- •2 ADEQUATE FAMILY SUPPORT.
- •3 PARTICIPATING PARENT/GUARDIAN MUST BE WILLING TO NOT TO APPLY ANY OTHER BODY MOISTURIZER THROUGHOUT THE STUDY.
排除标准
- •1 TODDLER WITH HISTORY OF DERMATITIS,ECZEMA,PSORIASIS,DIAPER RASH WILL BE EXCLUDED.
- •2 TODDLER WITH HISTORY OF SKIN ALLERGY OR HYPERSENSITIVITY.
- •3 TODDLER WITH ACTIVE LOCALIZED OR GENERAL INFECTION INCUDING UPPER RESPIRATORY INFECTIONS.
- •4 TODDLER WITH A KNOWN CONDITION OF ASTHMA OR ANY RELATED BREATHING PROBLEMS.
- •5 CONDITION THAT MAY INTERFERE WITH EVALUATION OF TRIAL RESULTS,EG.,MEDICAL CHARACTERISTICS,DISEASES AND THERAPY THAT MAY INTERFERE WITH THE EFFECT OF INVESTIGATIONAL PRODUCT OR WITH THE EVALUATION OF EFFICACY OR SAFETY VARIABLES.
结局指标
主要结局
PANCHAVALKALA KASHAYA EXTRACT SHOWER GEL MAY BE MORE EFFECTIVE ON DERMAL SAFETY WHEN COMPARED TO HIMALAYA GENTLE BABY WASH.
时间窗: 30 days
次要结局
- PANCHAVALKALA KASHAYA EXTRACT SHOWER GEL MAY BE MORE EFFECTIVE ON SKIN PARAMETERS AND DERMAL OF TODDLERS WHEN COMPARED TO HIMALAYA GENTLE BABY WASH.(30 DAYS)
研究者
Dr Likhitha MV
SDM Ayurveda college , hospital and research centre Udupi